PROTECT-TIMI 30 Trial

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00250471
First received: November 7, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.


Condition Intervention Phase
Unstable Angina
Procedure: Percutaneous Coronary Intervention (PCI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Efficacy: Improved Coronary Flow Reserve
  • Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.

Secondary Outcome Measures:
  • Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
  • Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial

Estimated Enrollment: 900
Study Start Date: May 2003
Estimated Study Completion Date: September 2004
Detailed Description:

Platelet inhibitor drugs

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:

    • diabetes
    • elevated cardiac proteins in the blood (indicating acute coronary syndrome)
  • Be willing and able to give informed consent

Exclusion Criteria:

  • uncontrolled hypertension
  • cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
  • prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
  • any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00250471     History of Changes
Other Study ID Numbers: 03-046
Study First Received: November 7, 2005
Last Updated: November 7, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
GP IIb/IIIa inhibitors
eptifibatide
Anti-thrombotic agents

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on October 19, 2014